Recognition and Control of Respiratory Hazards in the Flavoring Industry

1. Recognition and Control of Respiratory Hazards in the Flavoring Industry Training Developed by: Photo by National Jewish Health used with written permission.

2. Disclaimers This presentation was produced under grant number SH-22304-11-60-F-8 from the Occupational Safety and Health Administration, U.S. Department of Labor. It does not necessarily reflect the views or policies of the U.S. Department of Labor, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

3. Why are we here? Provide information to workers: • Signs and symptoms of potential flavor-related lung disease • Ways to detect lung disease that may be related to flavoring exposure • Methods to reduce exposure to flavorings associated with lung disease http://www.osha.gov/SLTC/flavoringlung/index.html accessed 3/28/2012

4. Outline Introduction to OSHA Overview of flavoring exposures Health effects of flavorings Medical surveillance (testing) for possible flavoring-related health effects Recognizing and controlling flavoring exposures

5. Definitions • Part per million (ppm) • Small unit of concentration • 1 ppm = 1 drop in 13 gallon gas tank • Flavoring exposure • Inhalation of flavoring vapors or particles • Bronchiolitis Obliterans Syndrome (BOS) • An uncommon lung disease where scars form in the small airways

6. Introduction to OSHATraining Goals Understand the role of OSHA in occupational safety and health Describe employer responsibilities and employee rights provided by OSHA Understand specific OSHA and industry standards for handling flavorings

7. What is OSHA? • Occupational Safety and Health Administration • Government agency within the U.S. Department of Labor • Responsible for worker safety and health protection • Created in 1970 by the Occupational Safety and Health (OSH) Act • OSH Act allows states to take responsibility for implementing OSH Act providing their regulations are at least as stringent as Federal OSHA

8. What does OSHA do? • Requires employers to implement programs to reduce workplace safety and health hazards • Investigates workplace fatalities or catastrophic accidents • Enforces safety and health standards through workplace inspections by compliance officers • Monitors job-related injuries and illnesses through required record-keeping • Provides assistance, training, and other support programs to help employers and workers

9. What are employers’ responsibilities under OSHA? Provide employment and a workplace that is: • In compliance with established OSHA standards. • Free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees.

10. What are employees’ rights under OSHA? • Get training from your employer as required by OSHA standards • Request information from your employer about OSHA standards, worker injuries/illnesses, and job hazards • Request action from your employer to correct hazards or violations of OSHA standards • File a complaint with OSHA if you believe there are violations of OSHA standards or serious hazards • Must be submitted in writing, signed by a current employee or employee representative, and state the reason for the inspection request • Forms and more information available at www.osha.gov

11. What are employees’ rights under OSHA? • Be involved in OSHA’s inspection of your workplace • Find out results of an OSHA inspection • Get involved in meetings or file a formal appeal concerning your employer’s timely abatement of OSHA citations • File a discrimination complaint • Request a research investigation by the National Institute for Occupational Safety and Health (NIOSH) • Provide comments and testimony to OSHA during rulemaking on new standards

12. Are there specific OSHA standards that apply to my workplace? • Lockout/tagout • Fire protection • Powered industrial trucks • Cranes • Machine guarding • Electrical • Respiratory protection • Exposure to toxic substances • Hazard communication • Recordkeeping • Housekeeping • Medical & First Aid • Walking/Work Surfaces • Emergency Action • Noise • Hazardous materials • Compressed gases • Flammable liquids • Personal protective equipment • Confined spaces There may also be others that apply to your workplace!

13. How are exposures regulated? OSHA sets legally enforceable limits Limits the total amount of flavoring you can inhale in a work day Makes sure that you don’t inhale too much flavoring in a short time • Permissible Exposure Limit (PEL) • Maximum permitted 8-hour time-weighted average concentration • Short-Term Exposure Limit (STEL) • 15-minute time-weighted average concentration not to be exceeded at any time during a workday • Ceiling Limit • Maximum concentration to which an employee may be exposed at any time Protects you from immediate irritation

14. Does OSHA have a standard for diacetyl? • OSHA – No PEL or Federal OSHA Standard • Currently working on developing a standard • CalOSHA (2010), No PEL • Exposure monitoring for airborne diacetyl • Regulated areas for all diacetyl processes • Controls to reduce exposures to lowest feasible levels • Medical surveillance (every 6 months) for workers • Respirators for workers • At all times when working with diacetyl-containing powders • When there are measurable diacetyl levels • 8-hour exposures are greater than 0.012 ppm • 15-minute exposures are greater than 0.035 ppm

15. Are there other groups that recommend exposure levels for diacetyl and substitutes? • NIOSH=National Institute for Occupational Safety and Health • ACGIH=American Conference of Governmental Industrial Hygienists • TERA=Toxicology Excellence for Risk Assessment Diacetyl 2,3-Pentanedione We don’t know which of these recommendations will be effective. Best approach is to reduce exposures as low as possible using these numbers to measure progress.

16. Are there OSHA standards for other flavorings? > 2,000 individual flavorings and < 100 with exposure limits

17. Overview of Flavoring ExposuresTraining Goals Understand that some flavorings may cause lung injury under some conditions Know where to find a listing of flavorings that may cause lung injury

18. Why are exposures hard to predict in flavoring manufacturing? More than 2,000 flavorings Some have irritant properties Small number have exposure limits Many with not enough information to determine whether they are a respiratory health hazard Exposures to different forms Pure flavorings Concentrated liquid and powder mixtures Low concentration final products Multiple processes Mixing, heating, packaging, etc. Batch processes Volumes vary Daily and seasonal variability Photo used by National Jewish Health with written permission. Not much information on possible hazards from breathing flavorings.

19. Is there a list of flavorings that might be hazardous when inhaled? Image by the Flavor and Extract Manufacturers Association Used with written permission “High Priority” flavorings should be labeled to alert workers that they require careful handling. • The Flavor and Extract Manufacturers Association (FEMA) has a list of “High Priority” flavorings • “High Priority” flavorings may cause respiratory injury when: • Exposure levels are high • Repeated exposures at lower levels • Processed using heat • Processed without proper exposure controls

20. What are the “High Priority” flavorings? Diacetyl & Substitutes • 2,3-Hexanedione • 3,4-Hexanedione • 2,3-Pentanedione • Acetoin • Diacetyl • DiacetylTrimer • 2,3-Heptanedione • Methyl Mercaptan • Methyl Sulfide • 2,4-Pentadienal • 2-Pentenal • Phosphoric Acid • Propionaldehyde • Propionic Acid • Sulfur Dioxide • Triethylamine • Valeraldehyde FEMA LISTED HIGH PRIORITY MATERIAL FOLLOW APPROPRIATE ENGINEERING AND PROCEDURAL CONTROLS TO MINIMIZE EXPOSURE Other Flavorings • Acetaldehyde • Acetic Acid • Benzaldehyde • Butyric Acid • Ethyl Acrylate • Formic Acid • Furfural • Hydrogen Sulfide • Isobutyraldehyde • Isobutryic Acid Figure by National Jewish Health These flavorings may cause respiratory injury when not handled properly.

21. What about natural flavoring complexes? Photo by Scott Bauer available under public domain from Wikimedia Commons Natural flavoring complexes may also cause irritation and respiratory symptoms when not handled properly. • Capsaicin • Oils • Balsam fir • Bitter almond • Garlic • Grapefruit • Lemon • Lime • Mustard • Onion • Orange

22. Health Effects and Medical SurveillanceTraining Objectives Learn about respiratory health effects Learn methods to detect possible flavoring-related health effects Understand the importance of medical surveillance 22

23. Definitions Normal Airway Image by National Jewish Health Narrow Airway Permanent Scarring Image by National Jewish Health • Airways • The tubes that carry air into and out of your lungs • Airway Disease • Airways become narrowed. • Causes slowing of the flow of air into and out of your lungs • Bronchiolitis Obliterans Syndrome (BOS) • Airway disease in small airways in the lungs • Injury from a chemical or infection • Scars form, causing airways to narrow. • Associated with exposure to diacetyl • Possibly diacetyl substitutes

24. Respiratory Health Effects Irritation Eyes, nose, throat Chest Skin irritation (high exposure) Airway diseases Bronchiolitis Obliterans Syndrome (BOS) Asthma Allergies Allergic reactions Asthma Diagram of a Normal Lung Image by National Jewish Health Air travels through the small airways to the air sacs and into the blood stream. 24

25. Cough Dry cough Cough with phlegm Wheeze Chest tightness Shortness of breath Airway irritation and airway diseases cause breathing symptoms. Photo by National Jewish Health Photo by National Jewish Health There are many causes of breathing symptoms. 25

26. A medical evaluation is needed to know the cause of the symptoms. • Colds and other infections • Cigarette smoking • Airway Irritation • Asthma • Bronchiolitis Obliterans Syndrome (BOS) • Allergies • Other lung diseases • Chronic obstructive pulmonary disease Photo by National Jewish Health 26

27. It is important to find BOS early! This is the true story of one worker 29 years old with no lung problems. He never smoked. He worked for 2 years as a flavor compounder. When he used a respirator, his beard prevented a good fit. He began to have breathing symptoms. He was treated for bronchitis. His symptoms continued to worsen. He had to stop working. He saw a doctor who knew about flavorings and BOS. He already had severe airway disease (BOS). He was not able to work or do many other things again. If his BOS had been diagnosed earlier, the ending to the story might have been different. 27

28. Flavorings can cause irritation and injury. Usually, there is only irritation Burning in the throat, nose, and eyes Burning in the chest, cough, and chest tightening Symptoms get better away from exposure Airway injury can occur High levels of exposure Very irritating flavorings Normal Airway Figure by National Jewish Health Photo by Cliff Hutson available under public domain from Wikimedia Commons • Not all “High Priority” flavorings are irritating. 28

29. Some flavorings can trigger asthma “attacks”. During an asthma “attack”: Airway muscles tighten. Airways become inflamed and narrowed. Symptoms may be mild or severe. Treatment with medications is often needed. Airways return to normal. Airways inflamed and narrowed Normal airway Asthma Medications Muscle tightening Mucus Swelling Figures by National Jewish Health 29

30. Asthma “attacks” can be triggered in workers who already have asthma. Triggered by irritant flavorings Capsaicin Some natural oils Some “High Priority” Flavorings Acetic acid Acetaldehyde (aldehydes) The higher the exposure, the higher the risk. Workers with asthma should be extra careful to avoid breathing in irritating flavorings. Photo by Cliff Hutson available under public domain from Wikimedia Commons 30

31. Some natural flavorings can cause allergic reactions. Notcommon in this industry Runny nose (rhinitis) Asthma Allergic reactions to Shellfish, fish, eggs, flour, some spices Rarely, a body-wide allergic reaction Hives Swelling of the mouth and throat Chest tightness, shortness of breath Allergic reactions to Shellfish, fish, some spices Peanuts and other tree nuts Photo available under public domain from Wikimedia Commons Photo by Bierfaß available under public domain from Wikimedia Commons 31

32. Bronchiolitis Obliterans Syndrome (BOS) is scarring in small airways. Diacetyl, possibly diacetyl substitutes After injury, scars form. Scars cause airways to narrow. Normal airway Late BOS Early BOS Airway injury Early Scarring Permanent Scarring Inflammation Images by National Jewish Health Diacetyl and diacetyl substitutes do not have good warning properties. 32

33. It is important to find BOS early! Early:Mild airway narrowing Mild breathing symptoms Removal from exposure can help prevent worsening. Late: Severe airway narrowing Severe breathing symptoms Nothing makes BOS better -- medications do not help. Late BOS Early BOS Normal airway Airway injury Early Scarring Permanent Scarring Inflammation Figures by National Jewish Health 33

34. Avoid breathing in diacetyl and substitutes. BOS has been found in workers exposed to butter flavorings. Popcorn manufacturing workers Flavor manufacturing workers Diacetyl production workers Photo by NIOSH available under public domain • These workers had exposure to high levels of diacetyl. • In animals, diacetyl causes airway injury and scars. • Diacetyl substitutes may not be better. It is important to keep exposures to diacetyl and diacetyl substitutes as low as possible. 34

35. It is important to find BOS early! If you are exposed to diacetyl or diacetyl substitutes: Report unexplained breathing symptoms to Human Resources or Health and Safety and to your doctor. Participate in medical surveillance. Photo by National Jewish Health 35

36. Talk to your doctor about your symptoms and your work with flavorings NIOSH 2011 Flavoring-Related Lung Disease (NIOSH) • Available on the NIOSH website (www.cdc.gov/niosh) 36

37. Medical Surveillance:Questionnaires and Breathing Tests Breathing Test (Spirometry) How much air you can breathe in and out How fast you can blow air out Testing is recommended at least every year. Every 6 months (CalOSHA) Are the results normal? Compared to other people who are your same age, height, and gender Are the results normal for you? Are the results similar to your past test results? Photo by National Jewish Health 37

38. Repeated breathing tests are needed. Normal 1) Is the result normal? Test After 5 Years of Work YES First Test 2) Is the result normal for you? NO YES 25 years of age Keep your test results. 38

39. Special tests are needed to diagnose work-related lung disease. If your test results are not normal for you Repeat the breathing test. If the test is still not normal for you, the doctor will do more testing to find out the cause. Photo by National Jewish Health Photo by National Jewish Health 39

40. Protect Your Lungs! Keep your exposure to all“High Priority” flavorings as low as possible. Do not rely on smell or irritation to warn you about exposure. Report new or worsening breathing symptoms. Don’t smoke! FEMA LISTED HIGH PRIORITY MATERIAL FOLLOW APPROPRIATE ENGINEERING AND PROCEDURAL CONTROLS TO MINIMIZE EXPOSURE Image by National Jewish Health Photo available under public domain from Wikimedia Commons 40

41. Flavoring Exposure Recognition and ControlTraining Goals Recognize flavorings and work processes where you might be exposed Understand the methods used to measure flavoring exposure Understand the proper use of control methods to reduce exposure to flavorings

42. How do I know if it is hazardous? Hazard Communication Figures by Torsten Henning available under public domain from Wikimedia Commons WARNING – This flavor may pose an inhalation hazard if improperly handled. Please contact your workplace safety officer before opening and handling, and read the MSDS. Handling of this flavor that results in inhalation of fumes, especially if the flavor is heated, may cause severe adverse health effects. Workers need to be alerted when working with “High Priority” flavorings Figure by National Jewish Health • Labeling of individual flavorings and compounded flavors • Handling precautions on batch sheets • Health effects • Proper handling • Necessary precautions • MSDS or SDS readily available

43. What does exposure to flavorings look like? Flavoring particles and vapors quickly move into a worker’s breathing zone unless removed at the source. Possible exposure anywhere “High Priority” flavorings are: • Sampled • Weighed • Mixed • Poured • Transferred • Packaged

44. How are exposures measured? Sample collector in “breathing zone” Worker “wears” sampling pump Photos by National Jewish Health Exposures can change depending on the tasks performed and the products produced. Particle/Dust Collectors Gas/Vapor Collectors • Personal air samples • Estimate the amount of flavoring a worker might inhale into their lungs • Workers wear sampling pump for entire work shift • Different air sampling collectors for different flavorings • Currently, no method for diacetyl powders

45. What does the level of exposure depend on? • Amount of “High Priority” flavoring used • Amount of time exposed • How well the vessels are sealed • Ventilation • Liquids • Pouring distance • Use of funnels • Powders • Hand scooping • Sifting • Packaging Short-term high exposures AND longer term lower exposures are both important. Photo used by National Jewish Health with written permission.

46. What levels of diacetyl havebeen measured in flavorings? QA Laboratories Liquid Compounding Average 8-Hour Exposures Average 8-Hour Exposures • 0.004 ppm (n=7) • 0.07 ppm (n=3) • 0.009 ppm (n=3) • 0.91 ppm (n=63) • 0.99 ppm (n=2) • 0.46 ppm (n=3) • 0.099 ppm (n=21) • 0.030 ppm (n=2) Photo used by National Jewish Health with written permission. Photo used by National Jewish Health with written permission. Powder Processing Spray Drying Average 8-Hour Exposures 8-Hour Exposure • 1.5 ppm (n=1) 2-Hour Exposures • 0.71 ppm (n=31) • 0.05 ppm (n=10) • 0.34 ppm (n=3) • 0.22 ppm (n=9) • 2.6 ppm (n=6) Photo used by National Jewish Health with written permission. Photo used by National Jewish Health with written permission. • 8-Hour Exposure Limits • NIOSH: 0.005 ppm • ACGIH:0.01 ppm • TERA: 0.2 ppm Many flavor worker tasks have short-term diacetyl exposures over 2 ppm. NJH OSHA Little information available on exposures to other “High Priority” flavorings. NIOSH

47. How are flavoring exposures controlled? High Exposure Changes in raw materials or flavorings Changes that capture or enclose the source of exposure Decreasing Effectiveness Changes in procedures or worker behavior to reduce exposure Increasing dependence on worker behavior Personal protective equipment: respirators, gloves, goggles, and protective clothing Acceptable Exposure

48. Does substitution work? O O O O O O O O Diacetyl Substitutes Diacetyl Larger molecules • Pros: • Lower exposures • Less evaporation at room temperature • Cons: • Chemically similar to diacetyl • May have similar health effects 2,3-Pentanedione 2,3-Hexanedione Until there is more information available, diacetyl and diacetyl substitutes should be controlled the same. 2,3-Heptanedione Figures by National Jewish Health

49. What is the best solution? Completely Enclosed Processes Photo by National Jewish Health used with written permission. May not be a realistic solution due to cost and production variability. Closed lines for all ingredients and finished products Closed vessel cleaning system Containment verified with air sampling Maintenance workers may still be exposed.

50. What is the next best solution? • Work Practice Controls Combination of controls used to reduce exposures to acceptable levels • Local Exhaust Ventilation • Process Isolation